Roche cobas p 480 v2 User guide

cobas p 480 v1 instrument

cobas p 480 v2 instrument

User Guide, Version 1.0

Software version 2.2

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

2

Publication information

Edition notice This publication is intended for users of the cobas p 480

v1 instrument and cobas p 480 v2 instrument.

Every effort has been made to ensure that all the

information contained in this publication is correct at the

time of publishing. However, the manufacturer of this

product may need to update the publication information

as output of product surveillance activities, leading to a

new version of this publication.

Where to find information The User Assistance contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• Configuration information

• Background information

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the

instrument.

The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

!

General attention

To avoid serious or fatal injury, ensure that you are

familiar with the system and safety information before you

use the system.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the instrument in a way that is not

described in this publication.

r Store all publications in a safe and easily accessible

place.

Training Do not carry out operation tasks or maintenance actions

unless you have received training from Roche

Diagnostics. Leave tasks that are not described in the

user documentation to trained Roche Service

representatives.

Publication version Software version Revision date Change description

1.0 2.2 September 2020 u What is new in publication version 1.0 (12)

y Revision history

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

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Images The screenshots and hardware images in this publication

have been added exclusively for illustration purposes.

Configurable and variable data in screenshots, such as

tests, results, or path names visible therein must not be

used for laboratory purposes.

Warranty Any customer modification to the system renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

Always leave software updates to a Roche Service

representative, or perform such updates with their

assistance.

reserved.

License information cobas p 480 software is protected by contract law,

copyright law, and international treaties. cobas p 480

software contains a user license between F. Hoffmann-La

Roche Ltd. and a license holder, and only authorized

users may access the software and use it. Unauthorized

use and distribution may result in civil and criminal

penalties.

Open source and commercial software cobas p 480 software may include components or

modules of commercial or open source software. For

further information on the intellectual property and other

warnings, as well as licenses pertaining to the software

programs included in cobas p 480, refer to the electronic

distribution included with this product.

This open source and commercial software and

cobas p 480 as a whole can constitute a device

regulated in accordance with applicable law. For more

detailed information, refer to the corresponding user

documentation and labeling.

Note that the respective authorization is no longer valid

according to the corresponding legislation should any

unauthorized changes be made to cobas p 480.

Trademarks The following trademarks are acknowledged:

COBAS and COBAS P are trademarks of Roche.

All other trademarks are the property of their respective

owners.

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

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Feedback Every effort has been made to ensure that this publication

fulfills the intended use. All feedback on any aspect of

this publication is welcome and is considered during

updates. Contact your Roche representative, should you

have any such feedback.

Approvals The cobas p 480 instrument meets the requirements laid

down in:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical

devices.

Directive 2011/65/EU of the European Parliament and of

the Council of 8 June 2011 on the restriction of the use of

certain hazardous substances in electrical and electronic

equipment.

Compliance with the applicable directive(s) is provided by

means of the Declaration of Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

directives.

Issued by CSA Group for Canada and the US.

Issued by the TÜV SÜD for Canada and the US.

'Laboratory Equipment' is the product identifier as

shown on the type plate.

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

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Contact addresses

Roche affiliates A list of all Roche affiliates can be found at:

www.roche.com/about/business/roche_worldwide.htm

eLabDoc Electronic user documentation can be downloaded using

the eLabDoc e-service on Dialog:

• www.dialog.roche.com

For more information, contact your local affiliate or Roche

Service representative.

cobas p 480 v2 instrument

Made in Switzerland by Hamilton Bonaduz AG for

Roche Molecular Systems, Inc.

1080 US Highway 202 South

Branchburg, NJ 08876

USA

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

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Table of contents 7

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

Table of contents

Publication information 2

Contact addresses 5

Table of contents 7

Intended use 9

Symbols and abbreviations 9

What is new in publication version 1.0 12

System description

1 Overview of the system

Instrument overview 17

Consumables overview 40

Operation

2 Overview of the instrument

Hardware overview 53

Supplies overview 56

3 Overview of operation

Overview of the workflow 63

Introduction to the user interface 68

4 Before operation

Before operation 79

5Operation

Basic operational tasks 85

Workflows 98

Error handling 128

6 After operation

Shutting down the system 145

7Maintenance

About periodic, specific, and preventive

maintenance 149

Maintenance schedule 151

Maintenance information in the user

interface 152

Daily maintenance 153

Weekly maintenance 165

8 Configuration

Changing laboratory name and the folder

location for reports 173

Changing the workflow settings 174

About managing users 176

Troubleshooting

9 Troubleshooting

Troubleshooting information in the user

interface 185

Stopping the instrument in exceptional

situations 187

Placing carriers when a stop hook is

broken 189

Restoring the instrument from a stop 190

Creating a problem report 207

Remote support 209

Appendix

10 Technical specifications

Instrument capacities 215

Specifications of instrument and software 216

Specifications of barcode readers and barcode

labels 219

Index 225

8 Table of contents

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

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Intended use

The cobas p 480 instrument is a stand-alone general

purpose laboratory instrument to minimize repetitive

manual tasks associated with specimen handling. This

instrument is intended to perform pre-analytical

processing, such as decapping and recapping, pipette-

and spin-mixing specimens, and aliquoting specimens to

secondary vials, of common sample types including but

not limited to PreservCyt

®

containers, SurePath

™

containers, Roche Cell Collection Medium, and cobas

®

PCR Media tubes. Additional hardware components and

programming flexibility allow automation of more

complex pre-analytical processes including reagent

addition and heating.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the

following product names and descriptors are used.

Terms

Product name Descriptor

cobas p 480 instrument instrument

cobas p 480 software software

cobas

®

PCR Media

CPM

PreservCyt

®

PC

Roche Cell Collection

Medium

PC

cobas

®

PCR Cell Collection

Media

PC

SurePath

™

SP

y Product names

Term Explanation

system Used when the emphasis is on

software and hardware as a

whole.

CPM cap Cap T01, 19 mm

CPM caps are replacement caps

for CPM tubes.

PC cap Cap, 42 mm

PC caps are replacement caps

for PC tubes.

MPA Workflows operating with 5-

position racks without stabilizers

for tubes with a diameter of

15.8 ± 0.2 mm.

y Terms

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

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Symbols used in the publications

Symbols used on product

Abbreviations The following abbreviations are used.

Symbol Explanation

o List item.

u Cross-reference to another topic.

q

Tip. Extra information on correct use or useful

hints.

I Extra information within a task.

f Result of an action within a task.

c Frequency of a task.

n Duration of a task.

d Materials that are required for a task.

j Prerequisites of a task.

w

Figure. Used in figure titles and cross-

references to figures.

y

Table. Used in table titles and cross-references

to tables.

z

Equation. Used in cross-references to

equations.

k

Code example. Used in code titles and cross-

references to codes.

y Symbols used in the publication

Symbol Explanation

Global Trade Item Number.

Catalog number

Serial number.

Date of manufacture.

Indicates that the equipment is suitable for

alternating current only; to identify relevant

terminals.

Caution

y Symbols used on product

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

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Abbreviation Definition

ANSI American National Standards

Institute

CSA Canadian Standards Association

EC European Community

EN European standard

ID Identification number

IEC International Electrical Commission

IFU Instructions for use

IVD In vitro diagnostic

LED Light-emitting diode

UI User interface

USB Universal serial bus

y Abbreviations

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

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What is new in publication version 1.0

cobas p 480 software version 2.2 provides the following

new features compared to software version 2.1.1:

Clean-up procedure After an automatic run abort, follow the new clean-up

procedure to unload all carriers and containers from the

instrument deck.

The clean-up procedure is available for all workflows. It

assists you in sorting successful samples for further

processing from samples that need to be checked and/or

rerun.

u Clean-up procedure to unload carriers and containers

after an automatic run abort (134)

User Assistance The content of the User Guide is now also available from

the cobas p 480 software. Choose the Help button on

the global action bar and access the User Assistance.

In addition, the following changes have been made in this

publication:

Information about cobas p 480 v1 instruments There is no dedicated User Guide for cobas p 480 v1

instruments available. When not otherwise specified, all

information in this publication refer to cobas p 480 v2

instruments. Specific information about cobas p 480 v1

instruments has been added in certain sections.

There is a single software version, which is suitable for

both instrument versions.

u cobas p 480 v1 instruments and cobas p 480 v2

instruments (17)

Links for further information The following information was added:

• Link to the worldwide list of Roche affiliates

• Link to the eLabDoc e-service on Dialog

Recapping workflow for SP containers Information about the recapping workflow for SP

containers has been removed. The cobas p 480 system

does not support this workflow anymore.

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

System description

1 Overview of the system........................................................................................ 15

1 Overview of the system

Roche Diagnostics

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Table of contents

Overview of the system 1

In this chapter

1

Instrument overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

cobas p 480 v1 instruments and cobas p 480 v2

instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

About the covers on the instrument . . . . . . . . . . . 18

About the LEDs on the instrument. . . . . . . . . . . . . 19

About the instrument deck . . . . . . . . . . . . . . . . . . . 20

About the autoload unit. . . . . . . . . . . . . . . . . . . 22

About the pipetting arm . . . . . . . . . . . . . . . . . . 24

About the grippers . . . . . . . . . . . . . . . . . . . . . . . 25

About the heating station . . . . . . . . . . . . . . . . . 26

About the decapper/recapper modules . . . . . 27

About the teaching needles . . . . . . . . . . . . . . . 28

About the solid waste station setup. . . . . . . . . 29

About carriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

About collection medium carriers . . . . . . . . . . 33

About secondary tube carriers . . . . . . . . . . . . . 36

About cap carriers . . . . . . . . . . . . . . . . . . . . . . . 37

About the reagent reservoir carrier . . . . . . . . . 38

About the tip rack carrier . . . . . . . . . . . . . . . . . 39

Consumables overview . . . . . . . . . . . . . . . . . . . . . . . . . 40

About the pipette tips . . . . . . . . . . . . . . . . . . . . . . . 40

About the reagent reservoirs . . . . . . . . . . . . . . . . . 41

About caps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

About solid waste consumables. . . . . . . . . . . . . . . 44

About primary containers and tubes . . . . . . . . . . . 44

Quick sample container barcode labeling guide . 47

About secondary tubes . . . . . . . . . . . . . . . . . . . . . . 48

1 Overview of the system

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

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Table of contents

1 Overview of the system

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

Instrument overview 17

Instrument overview

In this section

cobas p 480 v1 instruments and cobas p 480 v2

instruments (17)

About the covers on the instrument (18)

About the LEDs on the instrument (19)

About the instrument deck (20)

About carriers (32)

cobas p 480 v1 instruments and cobas p 480 v2

instruments

There are 2 instrument types available:

• cobas p 480 v1 instruments:

They support only decapping and recapping

workflows.

• cobas p 480 v2 instruments:

An additional pipetting arm with 4 pipetting channels

and a heating station support two further workflows:

the aliquot workflow and the heating and reagent

addition workflow.

When not otherwise specified, all information in this

publication refer to cobas p 480 v2 instruments.

From software version 2.2 onwards, the cobas p 480

software is delivered as a single application supporting

both instrument versions.

cobas p 480 v1 instruments The main differences of cobas p 480 v1 instruments

compared to cobas p 480 v2 instruments are:

• Only decapping and recapping workflows are

supported.

• No “PC-only” run types available for decapping or

recapping workflows.

• PC containers are placed in 12-position PC carrier

only. No 10-position PC carrier available.

• No MPA rack handling available.

• No heating station or pipetting arm.

1 Overview of the system

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

18 Instrument overview

Specific information about cobas p 480 v1 instruments is

available in the following sections:

u Example of the instrument deck layout for cobas p 480

v1 instruments w (20)

u Hardware overview about cobas p 480 v1

instruments (54)

u Supplies overview for cobas p 480 v1 instruments (57)

About the covers on the instrument

w Covers of the instrument

The front cover protects you from moving parts inside the

instrument. The front cover can be opened for user

interaction during maintenance. Always close the front

cover when you have finished maintenance work. During

a run, the front cover must be closed.

Solid waste door The solid waste door gives you access to the small solid

waste bag or the waste chute. During a run, the solid

waste door is locked and must stay closed.

A Left side cover C Right side cover

B Front cover D Solid waste door

A

C

B

D

1 Overview of the system

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

Instrument overview 19

NOTICE

Loss of materials due to forced opening of front

cover

The front cover is locked during a run. Forcing the front

cover open during a run, causes an emergency stop. The

run is aborted and all on-board reagents and in-process

samples are lost.

r Do not attempt to start the run with the cover open.

About the LEDs on the instrument

The LED bar above the autoload tray indicates the loading

status on the instrument deck. The status LEDs inform

you where to place the carriers on the autoload tray and

which tracks on the instrument deck have a carrier on

them.

A Track

B LED bar above the autoload tray indicating the

loading status

A

B

LED status Meaning User action

No light No carrier loaded. No action necessary.

Green light steady Carrier loaded on this track. No action necessary.

Green light blinking Carrier can be loaded on this track. Place the carrier on the autoload tray on

the indicated tracks. Insert the carrier

until it touches the stop hook.

y Status LEDs on LED bar

1 Overview of the system

Roche Diagnostics

cobas p 480 v1 and v2 instrument · Software version 2.2 · User Guide · Version 1.0

20 Instrument overview

About the instrument deck

The work area of the instrument is called instrument deck.

The instrument deck holds the following items:

• Removable carriers for samples, secondary tubes,

caps, reagents, and tips.

• Two decapper/recapper modules for decapping and

recapping of PC/SP containers and tubes.

• The heating station (optional) for sample incubation.

Instrument deck layout The instrument deck is divided into 43 equal tracks. The

tracks are numbered so that the location where a carrier

must be loaded can be identified. The track positions are

stamped on the surface of the autoload tray. A

corresponding LED on the LED bar above the autoload

tray indicates the loading status of each track.

Track assignment is workflow- and media-specific. The

instrument deck layouts below show an example of the

areas for each carrier type for cobas p 480 v1

instruments and cobas p 480 v2 instruments.

w Example of the instrument deck layout for cobas p 480 v1 instruments

A Cap carrier

B Collection medium carriers with PC/SP containers

C Error carrier

A B C

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